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Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy

Phase 1
40 Years
85 Years
Not Enrolling
Neovascular Maculopathy, Age Related Macular Degeneration

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Trial Information

Histocompatibility Leukocyte Antigen (HLA)-A*2402 and A*0201 Restricted Peptide Vaccine Therapy in Patients With Neovascular Maculopathy

VEGF receptor 1 and 2 are essential targets to pathogenic angiogenesis, and we identified
that peptides derived from these receptors significantly induce the effective tumor specific
CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the
safety, immunological and clinical response of those peptides. Patients will be vaccinated
once a week for 12 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide
(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. In the
study, our primary aim is to evaluate the safety and tolerability of these peptide vaccine.
The second aim is evaluate the immunological and clinical response of this vaccine therapy.

Inclusion Criteria:

- Neovascular Maculopathy including Age Related Macular Degeneration.

- Resistant against PDT or Anti VEGF therapy or Patient disagree with these therapies.

- with HLA-A*2402 or A*0201

Exclusion Criteria:

- Pregnancy(woman of childbearing potential:Refusal or inability to use effective means
of contraception) Breastfeeding Active or uncontrolled infection Unhealed external
wound Concurrent treatment with steroids or immunosuppressing agent Uncontrolled
brain and/or intraspinal lesion(s) Decision of unsuitableness by principal
investigator or physician-in-charge

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of this trial will be assessed based on National Cancer Institute-Common Toxicity Criteria,(NCI-CTC) version3. In case grade 4 or more complications occur, we will report the case to the review board within 14 days.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Kohji Nishida, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chair of Ophthalmology, Osaka University Medical School


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

October 2008

Completion Date:

April 2012

Related Keywords:

  • Neovascular Maculopathy
  • Age Related Macular Degeneration
  • Macular Degeneration